Tegosience, TPX-114 Phase 3 Clinical Trial Completion Report

Monitoring Completed for Cell Therapy Product Treating Full-Thickness Rotator Cuff Tears

[Asia Economy Reporter Hyungsoo Park] TegoScience announced on the 16th that it has reported to the Ministry of Food and Drug Safety the completion of the phase 1/3 clinical trial evaluating the safety and efficacy of TPX-114, an autologous cell therapy for patients with full-thickness rotator cuff tears.

Rotator cuff tears, referring to tears in the shoulder tendons, are one of the common conditions occurring in the elderly. Degenerative changes or sports injuries are considered causes of onset. To treat rotator cuff tears, suturing surgery is performed or medications are administered to reduce inflammation and pain. Unlike existing treatments, TPX-114 is an advanced biopharmaceutical aiming for fundamental treatment by regenerating the damaged shoulder tendons.

TPX-114 began phase 1 clinical trials in 2018 at Bundang Seoul National University Hospital and Seoul National University Hospital. Monitoring of subjects for the phase 3 clinical trial has been completed. The phase 1 clinical trial results were already published last year in the Orthopedic Journal of Sports Medicine, gaining academic recognition for its efficacy. A TegoScience representative stated, "With the completion of the TPX-114 clinical trial, we plan to immediately start efficacy evaluation for product approval application."

TegoScience also completed the phase 1/2 clinical trial of TPX-115, an allogeneic cell therapy for partial-thickness rotator cuff tears, in March and reported it to the Ministry of Food and Drug Safety.